the Neurology Advisor take:

The drug, which combines generic cough suppressant dextromethorphan and generic quinidine, used to control irregular heartbeats, is the same drug combo that the company used in its approval for Nuedexta as a treatment for uncontrolled outbursts of emotion seen in pseudobulbar effect.

In the 10-week, randomized, placebo-controlled clinical trial of AVP-923, significant reductions in agitation were observed by both the primary and secondary endpoints of the neuropsychiatric inventory (NPI). Reductions in agitation were observed in both stage 1 (p=0.0002) and stage 2 (p=0.021) of the Sequential Parallel Comparison study design.

Improvements in secondary endpoints included total NPI score (p=0.014), clinical global impression of change-agitation (p=0.0003) and measures of caregiver burden (p≤0.05). While AVP-923 was generally well-tolerated, the most common adverse reactions included falls, diarrhea and urinary tract infections.

Following the trial’s positive results, Avanir plans to request meetings with both the FDA and European Medicines Agency to discuss further use of dextromethorphan programs in clinical studies related to Alzheimer’s disease.

Still, there is some concern over the “new” drug, which actually combines two old ones. The FDA has been calling for more innovative therapies for the treatment of Alzheimer’s, and members of US Congress will likely balk if Avanir attempts to price the generic drug combo as a high-priced therapy.

Avanir's combinatorial approach to calming dementia-related outbursts among Alzheimer's patients caught the attention of Wall Street on Monday morning. The biotech touted mid-stage data demonstrating that a match of two treatments – a generic cough suppressant and a long-approved treatment for irregular heartbeats – significantly reduced the level of agitation among the patients in the study.

The results highlight the importance of evaluating and monitoring cognitive function in individuals with recent critical illness or major infections, especially if they are already at risk for dementia.